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PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men
ISRCTN ISRCTN94465371
DOI 10.1186/ISRCTN94465371
ClinicalTrials.gov identifier
EudraCT number 2012-002373-56
Public title PRe-exposure Option for reducing HIV in the UK: an open-label randomisation to immediate or Deferred daily Truvada for HIV negative gay men
Scientific title
Acronym PROUD
Serial number at source 13131
Study hypothesis The aim of this study is to assess what happens when a new approach, known as PrEP, is added to the existing methods available to gay men in the UK to reduce their risk of catching HIV infection.

PrEP is short for pre-exposure prophylaxis. Prophylaxis is taking a drug to prevent, or at least reduce the risk of, catching an infection. In this study we will use a drug called Truvada, which is commonly used to treat Human immunodeficiency virus (HIV). It is a combination of tenofovir and emtricitabine in a single pill, to be taken once a day.

A major concern about HIV negative individuals taking PrEP, is that they will decrease their use of other methods such as condoms, thereby increasing their risk of HIV and other sexually transmitted infections. This can only be assessed when people know they are taking an active drug.

This study will therefore offer people PrEP on an ‘open label’ basis, meaning that everyone who takes it will know they are taking the drug; no-one will take an inactive placebo pill.

In order to assess what happens when PrEP is added, we will need to follow one group for a period before the PrEP is included, at a time when they are accessing the best available methods for reducing risk. To do this, half of the volunteers will be offered PrEP immediately, and the other half after 12 months.

All participants will be offered other interventions to reduce their risk. They will be followed in clinic every 3 months for 2 years, and tested for HIV. A screen for sexually transmitted infections will be done every 6 months or more frequently if indicated. In between visits, participants will be asked to complete a diary and monthly questionnaire reporting anal intercourse and their pill taking when they are on Truvada.

More detail can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13131
Lay summary Not provided at time of registration
Ethics approval First MREC approval date 02/10/2012, ref: 12/LO/1289
Study design Randomised interventional study
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
Participants - inclusion criteria 1. Born to male gender, age 18 years or more
2. Previously attended the enrolling clinic on at least one occasion
3. Completed a screen for HIV and sexually transmitted infections (STIs)
4. HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomisation
5. Reported unprotected anal intercourse (UAI) on more than one occasion within the 90 days prior to randomisation
6. Likely, in the opinion of the volunteer, to have UAI in the next 90 days
7. Willing and able to comply with the visit schedule throughout the follow-up period
8. Willing and able to provide written informed consent
Participants - exclusion criteria 1. An acute viral illness that could be due to HIV seroconversion
2. Any contraindications to Truvada according to the current package insert
3. Treatment for hepatitis B infection indicated or ongoing
4. Unlikely, in the opinion of the clinician, to comply with the randomised allocation
Anticipated start date 29/11/2012
Anticipated end date 28/11/2013
Status of trial Completed
Patient information material
Target number of participants UK Sample Size: 500
Interventions Truvada - immediate or deferred; Follow Up Length: 24 month(s)
Primary outcome measure(s) Time to accrual; Timepoint(s): time to accrual of 500 participants
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 1. Gilead Sciences Inc (USA)
2. Health Protection Agency (HPA) (UK)
3. Medical Research Council (MRC) (UK)
Trial website http://www.proud.mrc.ac.uk
Publications
Contact name Dr  Sheena  McCormack
  Address MRC CTU
Aviation House
125 Kingsway
  City/town London
  Zip/Postcode WC2B 6NH
  Country United Kingdom
  Email smc@ctu.mrc.ac.uk
Sponsor Medical Research Council Clinical Trials Unit (MRC CTU) (UK)
  Address Aviation House
125 Kingsway
  City/town London
  Zip/Postcode WC2B 6NH
  Country United Kingdom
  Sponsor website: http://www.ctu.mrc.ac.uk/
Date applied 28/02/2013
Last edited 28/02/2013
Date ISRCTN assigned 28/02/2013
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